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AB-2942 Novel Allogeneic Adipose Cell-Based Viral Therapies Clinical Trials Grant Program.(2023-2024)

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Date Published: 04/25/2024 09:00 PM
AB2942:v97#DOCUMENT

Amended  IN  Assembly  April 25, 2024
Amended  IN  Assembly  March 21, 2024

CALIFORNIA LEGISLATURE— 2023–2024 REGULAR SESSION

Assembly Bill
No. 2942

Introduced by Assembly Member Villapudua
(Coauthor: Assembly Member Weber)

February 15, 2024

An act to add and repeal Article 5 (commencing with Section 104211) of Chapter 2 of Part 1 of Division 103 of the Health and Safety Code, relating to public health.


LEGISLATIVE COUNSEL'S DIGEST


AB 2942, as amended, Villapudua. Novel Allogeneic Adipose Cell-Based Viral Therapies Clinical Trials Grant Program.
Existing law provides various programs and funding to prevent and mitigate the impacts of cancer and other diseases in this state. Existing law defines the duties of the Treasurer, which include, but are not limited to, keeping an account of all money received and disbursed.
This bill would establish, upon appropriation by the Legislature, the Novel Allogeneic Adipose Cell-Based Viral Therapies Clinical Trials Grant Program to provide funding for clinical trials of novel allogeneic adipose cell-based viral therapies for cancer treatment. The program would be administered by the Treasurer, who would be required to award competitive grants to health facilities that meet specific requirements, including providing the Treasurer with specific patient safety data. The bill would require the Treasurer to award a significant amount of grant money to clinical trials conducted in low-income communities, traditionally excluded from leading-edge clinical trials. The bill would require the Treasurer to submit a report to the Legislature on the progress of clinical trials funded pursuant to the program, as specified.
This bill would repeal these provisions on January 1, 2031. The bill would make related findings and declarations.
Vote: MAJORITY   Appropriation: NO   Fiscal Committee: YES   Local Program: NO  

The people of the State of California do enact as follows:


SECTION 1.

 The Legislature finds and declares all of the following:
(a) Over 2,000,000 new cancer cases are expected to be diagnosed in the United States in 2024.
(b) Cancer survival is described by relative survival rate, which is the measure of life expectancy among cancer patients compared to that of the general population of the same age, race, and sex.
(c) Novel allogenic adipose cell-based cancer therapies are noninvasive alternatives to chemotherapy and radiation for triple negative breast cancer, ovarian cancer, nonresectable melanoma, squamous cell head and neck carcinoma, basal cell carcinoma, prostate cancer, sarcoma, and thyroid cancer.
(d) Currently, commercial and Medicaid insurance do not provide coverage for clinical trials of the novel allogenic adipose cell-based therapies.
(e) Racial disparities in cancer in the United States are striking and persistent. The death rate for Black people with prostate, stomach, and uterine cancer is double that of Caucasian people.
(f) American Indian and Alaska Native people have death rates for liver, stomach, or kidney cancer that are two times higher than Caucasian people.
(g) Black men have the highest overall cancer death rate.
(h) American Indian and Alaska Native people have the highest overall incidence and mortality rate for men and women combined.
(i) Black women with endometrial cancer have a death rate that is two times higher than that of White women despite similar incidence of the disease, partly because they are diagnosed later and have worse chances of survival.
(j) Most participants in clinical trials are White males. This calls into question the applicability of trial results across diverse populations.
(k) To close racial disparities in cancer treatment and increase access to care, barriers must be removed to accessing clinical trials.
(l) Typical trials require patients to repeatedly travel to a central site for assessments, administration of therapies, tests to monitor results, and medications to take at home. Clinical trials require patients to invest several hours per trip and to pay for transportation and food. These requirements create a selection bias by precluding from trials many people with little disposable income, few transportation options, inflexible work hours, and family care obligations.

SEC. 2.

 Article 5 (commencing with Section 104211) is added to Chapter 2 of Part 1 of Division 103 of the Health and Safety Code, to read:
Article  5. Novel Allogeneic Adipose Cell-Based Viral Therapies Clinical Trials Grant Program

104211.
 (a) The Novel Allogeneic Adipose Cell-Based Viral Therapies Clinical Trials Grant Program is hereby established.
(b) The purpose of the grant program is to provide funding for clinical trials of novel allogeneic adipose cell-based viral therapies for cancer treatment.

104211.1.
 (a) The Novel Allogeneic Adipose Cell-Based Viral Therapies Clinical Trials Grant Program shall be administered by the Treasurer.
(b) The Treasurer shall award grants on a competitive basis. The Treasurer shall establish minimum standards, funding schedules, and procedures for awarding grants. The Treasurer shall prioritize awarding grants to health facilities with a demonstrated commitment to patient safety and ethical research practices.
(c) A health facility that applies for a grant shall meet all of the following requirements:
(1) The health facility shall provide to the Treasurer patient safety data on adipose stem cells combined with vaccinia virus.
(2) The health facility shall have a proof of concept using allogeneic adipose cell-based viral therapies via a phase 1 safety or clinical trial.

104211.2.
 Grants awarded pursuant to this article shall be used pursuant to the following requirements:
(a) The first twenty million dollars ($20,000,000) of awarded grants shall be allocated for phase 1 of a clinical trial conducted pursuant to this article.
(b) A significant portion of grant money shall be used in clinical trials conducted in low-income communities, traditionally excluded from leading-edge clinical trials.
(c) Clinical trials funded pursuant to this article shall include wraparound services for participants from low-income communities. Wraparound services may include transportation, childcare, and paid medical leave.

104211.3.
 On or before July 1, 2026, or 18 Eighteen months following future appropriations by the Legislature, the Treasurer shall submit a report to the Legislature, in compliance with Section 9795 of the Government Code, on the progress of clinical trials funded pursuant to this article, including the impact on underserved communities and the success of wraparound services.

104211.4.
 This article shall be operative upon an appropriation by the Legislature to fund these provisions.

104211.5.
 This article shall remain in effect only until January 1, 2031, and as of that date is repealed.